Harmony® Prenatal Test for assessment of Down syndrome and other chromosomal disorders receives CE mark

The CE-IVD Harmony® Prenatal Test is a non-invasive prenatal test (NIPT) for pregnant women, based on cell-free DNA analysis. This blood screening test can be used as early as ten weeks into pregnancy. By evaluating fetal cell-free DNA found in maternal blood, including accurate measurement of the fetal fraction of DNA, the test assesses the probability of Trisomy 21 (Down syndrome) and other common fetal aneuploidies. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. Harmony® does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document.  Before making any treatment decisions, all women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate.

The Harmony Prenatal Test was originally developed as a laboratory developed test send-out and was validated by a robust clinical data set, and supported by clinical studies in more than 23,000 women ranging from 18-48 years of age in all risk categories. The Harmony Prenatal Test has been used to guide clinical care in over 850,000 pregnancies worldwide as a send-out test or locally performed test using RUO reagents ex-US. For more information, visit www.harmonytest.com.

About Roche
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Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

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Roche Sequencing Solutions Media Relations
Elizabeth Baxter
Phone: +1 925.523.8812
Email: elizabeth.baxter@roche.com

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SOURCE Roche